A host of DMPK in vitro and in vivo assays are readily available to probe the Absorption, Distribution, Metabolism and Excretion (ADME) properties of new molecular entities. I work with you to design resource sparing strategies that allow you to rapidly identify the most promising leads.
Understanding exposure - response relationships are critical to translating in vitro and preclinical in vivo models to human PK and dose. I leverage a tiered approach to generate predictions based on your in vitro and in vivo DMPK and pharmacology data.
Connecting PK with pharmacodynamic (PD) response requires rigorous problem solving and models linking biomarkers, target engagement and direct PD endpoints with exposure. I work with you to design experiments and generate data that drives your decision making.
Integrating in vitro inhibition and induction data into prediction of potential DDI liabilities allows risk assessment and management of potential liabilities. I help you navigate the complexities of interpreting data for metabolizing enzymes and transporters to ensure your regulatory submission packages are robust and appropriate.
Regulatory document preparation and review including reports, IBs, IND and CTD sections
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